Diclofenac Sodium

Product NDC
45865-436
Requested package NDC
45865-436-60
11-digit product format
458650436
Labeler code
45865
Product ID
45865-436_9adbe070-47a0-0df4-e053-2995a90a71e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Medsource pharmaceuticals
Application
ANDA074514
Marketing category
ANDA
Marketing start
1996-03-26
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
50 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage45865-43645865-436-60IInactivated by FDA2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074514-001DICLOFENAC SODIUMDICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26
A074514-002DICLOFENAC SODIUMDICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A074514-001AB
A074514-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074514-001DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1996-03-26782e0a99824c…
2021-12-28 21:50 UTC2021-12A074514-002DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1996-03-26782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074514-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074514-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074514-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074514-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074514-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074514-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074514-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074514-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074514-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074514-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074514-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074514-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074514-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074514-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074514-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074514-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074514-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074514-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074514-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074514-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074514-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074514-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074514-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074514-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074514-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074514-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074514-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074514-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074514-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074514-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074514-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074514-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074514-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074514-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074514-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074514-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074514-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074514-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074514-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A074514-002AB1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-436-30Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE301
45865-436-60Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-436DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20191230_9adbe021-4637-934d-e053-2995a90a5ae9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMGolden State Medical Supply, Inc.c1d87003-f54b-4381-9e11-1c39ea2d9eb32026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514
Diclofenac SodiumDICLOFENAC SODIUMPD-Rx Pharmaceuticals, Inc.663a3dbc-a631-4046-8852-ec619c41c81d2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions47793dca-5e9e-44ee-8e66-5e42e1831b1e2026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsb74be49d-74ff-491b-962b-0edd3a57cbc92026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514
Diclofenac SodiumDICLOFENAC SODIUMPD-Rx Pharmaceuticals, Inc.87d5a720-f154-4c4b-b2d4-0ae58455dda02025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPf5b4e308-c156-4865-95ee-1a8e267535ba2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514
Diclofenac SodiumDICLOFENAC SODIUMActavis Pharma, Inc.a57b897e-0cbe-4ac3-969f-b00357a0cfa82024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP77c3cb56-c071-4d92-a0d6-022417a27de42019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514
Diclofenac SodiumDICLOFENAC SODIUMAphena Pharma Solutions - Tennessee, LLCe4af374a-1281-46af-a0a9-48820db6c9472018-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074514
application number: ANDA074514

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN9adbe021-4637-934d-e053-2995a90a5ae91
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD9adbe021-4637-934d-e053-2995a90a5ae91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-436-604586504366060 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-436-60) 2018-12-120000-00-00NoNoCurrent